PMID- 28598103
OWN - NLM
STAT- MEDLINE
DCOM- 20181023
LR  - 20181023
IS  - 1672-173X (Print)
IS  - 1672-173X (Linking)
VI  - 47
IP  - 5
DP  - 2016 Sep
TI  - [Safety and Tolerance of Healthy People to Injection of Astragalosides-a New Drug 
      for Coronary Heart Disease].
PG  - 805-809
AB  - OBJECTIVES: To assess the safety and tolerance of healthy volunteers to as 
      tragalosides injection (AGI), and to determine a safe dose range for phase II 
      clinical trial. METHODS: A total of 62 healthy volunteers participated in this 
      study, with 26 being given a single AGI of 100 mL, 200 mL, 300 mL, 400 mL, 500 
      mL, or 600 mL and 36 subjects being given 500 mL, 400 mL, 200 mL or 300 mL of AGI 
      once a day for 7 d. Discomfortsymptoms, vital signs and safety problems were 
      recorded 3 d and 7 d after the administration of AGI. The results were analyzed. 
      RESULTS: Of the 62 participants, 40 adverse events (AEs) were reported by 31 
      participants, which included 23 mild adverse reactions (ADRs) and 4 moderate 
      ADRs. Nine AEs were reported by 9 participants with single AGI, including 7 ADRs. 
      Fourteen AEs were reported by 10 participants with 500 mL and 400 mL multiple 
      AGI, including 12 ADRs occurred in 9 participants.Seventeen AEs were reported by 
      12 participants with 300 mL and 300 mL multiple AGI, including 3 mild ADRs. The 
      main ADRs included abnormal liver function [slightly elevated glutamic pyruvic 
      transaminase (ALT), glutamic oxaloacetic transaminase (AST),and serum total 
      bilirubin (TBil)], low blood potassium, increased urine red blood cell count, 
      rash, and phlebitis. CONCLUSIONS: The maximum tolerance is 600 mL for single-dose 
      treatment, and 400 mL for multiple-dose (7 d). The dose guidance given in this 
      study should be examined its effects and safety in patients with coronary heart 
      disease in phase II clinical trial.
FAU - Zou, Chong
AU  - Zou C
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Liu, Fang
AU  - Liu F
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Jiang, Meng
AU  - Jiang M
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Xiong, Ning-Ning
AU  - Xiong NN
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Gao, Wei-Min
AU  - Gao WM
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Yu, Jing-Mei
AU  - Yu JM
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Yin, Jun-Gang
AU  - Yin JG
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Zou, Jian-Dong
AU  - Zou JD
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
FAU - Fang, Zhu-Yuan
AU  - Fang ZY
AD  - Affiliated Hospital of Nanjing University of TCM, Jiangsu Provincial Hospital of 
      TCM, Nanjing 210029,China.
LA  - chi
PT  - Journal Article
PL  - China
TA  - Sichuan Da Xue Xue Bao Yi Xue Ban
JT  - Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical 
      science edition
JID - 101162609
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Saponins)
RN  - 0 (Triterpenes)
SB  - IM
MH  - Coronary Disease/*drug therapy
MH  - Drugs, Chinese Herbal/*administration & dosage/adverse effects
MH  - Healthy Volunteers
MH  - Humans
MH  - Liver/drug effects
MH  - Saponins/*administration & dosage/adverse effects
MH  - Triterpenes/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Coronary heart disease
OT  - Phase I clinical trial
OT  - Safety and tolerance study
OT  - Total astragalosides
EDAT- 2017/06/10 06:00
MHDA- 2018/10/24 06:00
CRDT- 2017/06/10 06:00
PHST- 2017/06/10 06:00 [entrez]
PHST- 2017/06/10 06:00 [pubmed]
PHST- 2018/10/24 06:00 [medline]
PST - ppublish
SO  - Sichuan Da Xue Xue Bao Yi Xue Ban. 2016 Sep;47(5):805-809.